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March 14, 2019
Neil Kumar, Ph.D.
Chief Executive Officer
BridgeBio Pharma LLC
421 Kipling Street
Palo Alto, CA 94301
Re: BridgeBio Pharma LLC
Draft Registration Statement on Form S-1
Submitted on February 14, 2019
CIK No. 0001743881
Dear Dr. Kumar:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so we may
better
understand your disclosure.
Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1 submitted on February 14, 2019
Prospectus Summary
Overview, page 1
1. We note your disclosure that several of your programs target potential
"blockbuster"
opportunities. Please tell us the definition you use to define a
blockbuster opportunity, and
place this selected disclosure in appropriate context by specifying the
programs and
indications you believe present blockbuster opportunities and whether
the related
programs are in the clinical, preclinical or lead optimization stage.
For those programs
that are lead optimization or preclinical stage, please tell us why you
believe it is
appropriate to characterize these as blockbuster opportunities given the
early stage of
development.
Neil Kumar, Ph.D.
FirstName Pharma LLC Kumar, Ph.D.
BridgeBio LastNameNeil
Comapany2019
March 14, NameBridgeBio Pharma LLC
March 14, 2019 Page 2
Page 2
FirstName LastName
Our Platform, page 2
2. We note your disclosure that you "rapidly" advance your product
candidates to objective
critical decision points. Please revise your disclosure and similar
statements throughout
your registration statement, e.g., on page 31, to remove any
implication that you will be
successful in commercializing your product candidates in a rapid or
accelerated manner as
these statements are speculative for you to make. Similarly, please
remove statements that
imply you will be successful in mitigating risk associated with drug
development, such as
your statement on page 114 that you "avoid taking on the risk
associated with scientific
uncertainties often seen with novel modalities" and your statements
throughout that you
focus on programs that you believe to be "lower development risk."
Our Pipeline, page 3
3. We note your reference to "promising" oncology programs and other
references to your
product candidates as potential "first-in-class" or "best-in-class"
therapies. These terms
suggest that the product candidates are effective and likely to be
approved. Please delete
these references throughout your registration statement. If your use
of these terms was
intended to convey your belief that the products are based on a novel
technology or
approach and/or is further along in the development process, you may
discuss how your
technology differs from technology used by competitors and, if
applicable, that you are
not aware of competing products that are further along in the
development process.
Statements such as these should be accompanied by cautionary language
that the
statements are not intended to give any indication that the product
candidates have been
proven effective or that they will receive regulatory approval.
4. Please refine the description of your pipeline by categories so that
it presents a balanced
view of the status of such programs. For example, please state that
three out of four of
your oncology product candidates are in the lead optimization phase.
5. Please tell us why you believe that BBP-265, BBP-831, BBP-631 and
BBP-454 have the
greatest potential to drive near-term value. We note other similarly
situated programs in
your pipeline in terms of stage of development and patient population.
In addition, BBP-
631 and BBP-454 are in very early stages of development, so it is
unclear how they would
provide value in the near-term. Please also clarify if you intend to
prioritize the funding
of these programs over your other programs, as is suggested by
disclosure on page 15 and
elsewhere in your filing.
6. We note your disclosure on pages 5 and 133 concerning the development
plan for BBP-
831/Infigratinib. As you have not yet commenced any Phase 3 trials or
submitted a new
drug application (NDA) for this product candidate for any indication,
please shorten the
arrow in your pipeline development chart so that it reflects the
current stage of
development. Please also revise the "Current Status" column in the
chart on page 116
accordingly. In addition, please clarify that your preparation for an
NDA submission is
with respect to BBP-831 only for use as a second-line therapy.
Neil Kumar, Ph.D.
FirstName Pharma LLC Kumar, Ph.D.
BridgeBio LastNameNeil
Comapany2019
March 14, NameBridgeBio Pharma LLC
March 14, 2019 Page 3
Page 3
FirstName LastName
7. Please tell us what is meant that three of your product candidates are
"Registrational." To
the extent this indicates that they have completed the trial prior to
your submission of an
NDA, we note your disclosure on page 133 that you expect to enroll
approximately 20
additional subjects in the ongoing CCA Phase 2 clinical trial and your
Phase 2 clinical
trial for BBP-870 is also ongoing. Please tell us the significance of
indicating that these
trials are registrational as opposed to indicating their current
status or that they have
completed a particular trial phase.
8. Your pipeline table appears to include every in-house development
program. Please
revise the table to include only those programs that are material to
the company. If you
believe that every program listed is material, please provide us with
an analysis explaining
your belief. In particular, to the extent your programs in the lead
optimization stage are
material to the company, please discuss this in your analysis.
Who Should Invest, page 4
9. Please delete the disclosure in this section as it presents itself as
a disclaimer that only
particular investors should invest in the company.
Risks Associated with Our Business , page 7
10. Please expand your disclosure in the fourth bullet point to highlight
the risks associated
with developing gene therapy candidates, as discussed on pages 28 to
31. Please also
expand the disclosure in the seventh bullet point to disclose
competition with respect to
your key value drivers, as discussed on page 60, and in the
penultimate bullet point to
disclose pending patent litigation, as discussed on page 45.
Additionally, please add a
bullet point to highlight the risk that as a result of concentration
of share ownership,
existing shareholders will be able to exert significant influence over
matters subject to
shareholder approval, as discussed on page 73, and a bullet point
discussing the risk that
you may expend your limited resources to pursue a particular product
candidate and fail to
capitalize on more profitable development opportunities.
Implications of Being An Emerging Growth Company, page 9
11. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Use of Proceeds, page 82
12. Please expand your disclosure to specify the intended use of proceeds,
including the
amount you intend to allocate to each product candidate individually
and how far the net
proceeds are expected to allow you to continue in the development for
each of your
product candidates. Refer to Item 504 of Regulation S-K.
Neil Kumar, Ph.D.
FirstName Pharma LLC Kumar, Ph.D.
BridgeBio LastNameNeil
Comapany2019
March 14, NameBridgeBio Pharma LLC
March 14, 2019 Page 4
Page 4
FirstName LastName
Reorganization, page 84
13. We note that, in connection with your corporate reorganization, you
will issue shares of
BridgeBio Pharma, Inc. to holders of existing units in BridgeBio
Pharma LLC in
exchange for the LLC units. Please tell us whether you are relying on
an exemption from
registration for the issuance to unitholders, including the facts
supporting
such exemption.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates
Equity-Based Compensation, page 101
14. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the units underlying your equity
issuances and the reasons for
any differences between the recent valuations of your units leading up
to the IPO and the
estimated offering price. This information will help facilitate our
review of your
accounting for equity issuances including stock compensation and
beneficial conversion
features.
Business
Key Value Drivers
BBP-265/AG10 (Eidos): TTR Amyloidosis
Our Product Concept, page 118
15. We note your reference to cross-study comparisons of clinical data
here and presentation
of prospective and retrospective study data on pages 117, 118 and 120,
including the chart
on page 120, and your discussion of cross-trial comparisons with
respect to additional
product candidates on pages 128, 129, 135, 138, 150 and 151. Please
remove any
comparisons with third party treatments, including your perceived
advantage over existing
therapies and therapies in development, such as those discussed on
page 125, as the data
and your conclusions are not based on head-to-head studies.
BBP-831/Infigratinib (QED): FGFR-Driven Cancers
Clinical Data, page 129
16. We note statements throughout stating that Infigratinib has shown
"meaningful clinical
activity" and "significant clinical activity." Please tell us what you
mean by meaningful
and significant, including the measurements you are using to make such
determinations.
17. Please expand your disclosure to include the objective data points for
each of ORR, PFS,
BOR, DCR and OS, and how the interim analysis results compare to the
established
endpoints. Please provide similar disclosure for the trial discussed
on page 131 and in
your discussion of results on page 133 so that investors can
understand the significance of
the results.
Neil Kumar, Ph.D.
FirstName Pharma LLC Kumar, Ph.D.
BridgeBio LastNameNeil
Comapany2019
March 14, NameBridgeBio Pharma LLC
March 14, 2019 Page 5
Page 5
FirstName LastName
18. Please explain the significance of the waterfall charts on pages
130-131.
19. We note your statement on page 133 that your plan to discuss the
marketing authorization
pathway for the companion diagnostic you are developing. On page 37
you note that the
FDA will likely require the conduct of clinical trials to demonstrate
the safety and
effectiveness of diagnostics, which you expect will require separate
regulatory clearance
or approval. Please revise your disclosure to explain how approval of
your diagnostic tool
for BP-831 impacts the timing of approval and/or commercialization of
BBP-831. Please
also disclose the impact to approval and or/marketing of BBP-831 if
the diagnostic tool is
not approved.
Safety Data, page 131
20. Please disclose all serious adverse events experienced by patients
exposed to infigratinib,
whether or not treatment related, including the incidence of each
serious adverse event.
BBP-870 (Origin): MoCD Type A, page 144
21. Please disclose all serious adverse events that occurred in the Phase
2 and Phase 2/3
clinical trials, whether or not related to BBP-870.
BBP-009/Patidegib (PellePharm): Gorlin Syndrome and High Frequency Basal Cell
Carcinoma,
page 148
22. Please disclose the primary and secondary endpoints for each of the
Phase 2 clinical trials
in terms of their objective data points and how the results of the
studies compared to the
endpoints. Please also disclose data supporting your statement that
the Phase 2 trial
showed statistically significant levels of clearance of BCCs after
three months. Please
ensure that you present a complete picture of all results so that
investors can understand
the significance of the results that you cite. Please also disclose
all serious adverse events,
whether or not treatment-related.
Intellectual Property, page 173
23. Please expand your disclosure to indicate the relevant jurisdiction
for each of your foreign
patents. Refer to Item 101(c)(1)(iv) of Regulation S-K.
Our Material Agreements
BBP-831 License Agreement with Novartis International Pharmaceutical Ltd. ,
page 177
24. Please expand your disclosure to quantify the value of the shares of
Series A preferred
stock to be issued to Novartis under the license agreement. Please
provide similar
disclosure with respect to the common shares issued to Lotus under the
asset purchase
agreement for BPP-589 referenced on page 177 and with respect to the
common
shares issued under the collaboration and license agreement with the
Board of Regents of
the University of Texas System, as referenced on page 180.
Neil Kumar, Ph.D.
BridgeBio Pharma LLC
March 14, 2019
Page 6
BBP-009 (Patidegib): Option Agreement with LEO Pharma A/S, page 178
25. Please disclose the certain events that would prevent LEO Pharma from
exercising its
option to acquire PellePharm.
General
26. Please ensure that all graphics are legible, including your pipeline
development
charts, and provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Rolf Sundwall at 202-551-3105 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Christine Westbrook at 202-551-5019 or Erin Jaskot at 202-551-3442 with
any other
questions.
Sincerely,
FirstName LastNameNeil Kumar, Ph.D.
Division of
Corporation Finance
Comapany NameBridgeBio Pharma LLC
Office of
Healthcare & Insurance
March 14, 2019 Page 6
cc: Maggie Wong, Esq.
FirstName LastName